Orelabrutinib and Obinutuzumab for Treating Marginal Zone Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, prospective study aims to evaluate the efficacy and safety of a combination of Orelabrutinib and Obinutuzumab for patients with previously untreated Marginal Zone Lymphoma (MZL). The trial will involve administering six cycles of the O2 regimen, followed by a year of single-agent Orelabrutinib for patients who achieve a complete or partial response. MZL is a common type of B-cell non-Hodgkin lymphoma, and this study seeks to explore a chemotherapy-free treatment approach that may reduce safety risks associated with traditional regimens. The study is designed to provide valuable insights into effective treatment options for MZL patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged ≥18 years, gender not limited;
* Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL;
* MZL that has progressed, recurred, or is not suitable for local treatment after previous local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, and hepatitis C treatment);
* ECOG 0-2;
* Indication for treatment as judged by the investigator (symptomatic, with cytopenia, at risk of end-organ damage, bulky disease, persistent progression, or patient\'s desire for treatment);
* Major organ function meets the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow invasion, absolute neutrophil count ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; b) Blood biochemistry: Total bilirubin ≤1.5 ULN, AST or ALT ≤2 ULN; serum creatinine ≤1.5 ULN; serum amylase ≤ULN; c) Coagulation function: International normalized ratio (INR) ≤1.5 ULN.
* Expected survival time ≥3 months;
* Voluntarily sign a written informed consent form before the trial screening.

Exclusion Criteria:

* Currently or previously diagnosed with other malignant tumors, unless curative treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years;
* Lymphoma involving the central nervous system or transformation to a higher grade;
* Active bleeding within 2 months prior to screening, or currently taking anticoagulant medications, or the investigator considers there to be a definite bleeding tendency;
* Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening;
* Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb and positive for HBV DNA titer), HCV Ab positive, HIV/AIDS, or other serious infectious diseases;
* Any mental or cognitive disorder that may limit the understanding, execution, and compliance with the informed consent form and the study;
* Pregnant or lactating women and women of childbearing age who are unwilling to take contraceptive measures;
* Need to continuously take drugs with moderate to severe inhibitory or strong inductive effects on cytochrome P450 CYP3A;
* Other conditions that the investigator considers unsuitable for participating in this trial.

Where it's running

• The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#
  Huai'an, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Chunling Wang
• Email: wcl6506@163.com
• Phone: 15189552696

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

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• Orelabrutinib combined with BR/G for untreated Marginal Zone Lymphoma

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• Combining Orelabrutinib and Rituximab for Treating Marginal Zone Lymphoma

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  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT06478472

• Combining obinutuzumab and lenalidomide for treating relapsed marginal zone lymphoma

  This study is testing a combination of two medications, obinutuzumab and lenalidomide, to see if they can help people with relapsed marginal zone lymphoma feel better.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.